Is compounded semaglutide still legal? Status as of August 2026

Yes, but on much narrower terms than the ones that built the market — and the narrowing happened on dates that have already passed. The shortage-based pathway that let pharmacies make copies of semaglutide closed on April 22, 2025 for state-licensed pharmacies and May 22, 2025 for outsourcing facilities¹. Checked against the FDA drug shortage database on August 28, 2026, neither semaglutide injection nor tirzepatide injection appears on the current shortage list⁵. What remains legal is ordinary patient-specific compounding under section 503A, plus one FDA enforcement statement that is doing a great deal of work. Here is the rule and the date attached to each piece of it. Nothing below is a forecast.

The dates that closed the shortage pathway

Compounding a copy of an approved drug is restricted under both sections of the law, and the restriction lifts while the drug is on FDA's shortage list. FDA keeps a dated log of when each entry ended and how long compounders had to wind down¹.

For tirzepatide, FDA first determined the shortage resolved on October 2, 2024, had that decision remanded for reevaluation in litigation, and issued a new decision on December 19, 2024 reaching the same conclusion. The wind-down ran to February 18, 2025 under 503A and March 19, 2025 under 503B; on March 5, 2025 a district court denied the plaintiffs' preliminary injunction motion, after which FDA stated the 503A period "has ended"¹. For semaglutide, FDA determined the shortage resolved on February 21, 2025, with wind-downs to April 22, 2025 for 503A and May 22, 2025 for 503B; a court denied the preliminary injunction motion on April 24, 2025, and FDA confirmed the 503A period had ended¹.

What the shortage list says right now

Read on August 28, 2026, with the database's most recent entries dated August 27, 2026: semaglutide injection and tirzepatide injection appear in no current-shortage row, while liraglutide injection is listed as currently in shortage. Semaglutide tablets appear too, but under discontinuations — a notice posted June 4, 2026 covering Rybelsus 3 mg, 7 mg, and 14 mg, recorded as "discontinuation of the manufacture of the drug" and noting the products "will be replaced by Ozempic (semaglutide) tablets"⁵. A discontinuation is not a shortage, and FDA has published nothing tying that entry to compounding status. One caveat belongs on all of this, because the database displays it itself: FDA warns the shortage database "is currently experiencing technical difficulties and some of the information contained in the database may not reflect the current supply status"⁵. FDA's own compounding page, current as of April 1, 2026, states the position directly: "Tirzepatide and semaglutide do not currently appear on the 503B bulks list or on FDA's drug shortage list"¹.

What section 503A still permits

A state-licensed pharmacy or physician can still compound semaglutide, but two conditions govern it. The product must be compounded for an individual patient on receipt of a prescription, and the compounder must not compound, "regularly or in inordinate amounts," products that are essentially copies of a commercially available drug¹. FDA defines an essential copy as a product with the same active ingredient in the same, similar, or easily substitutable strength that can be given by the same route — unless a prescriber determines and documents a change producing a significant difference for that identified patient¹.

Combination products get the same treatment. FDA's published example is semaglutide plus vitamin B12, which it may consider an essential copy of two commercially available products when the route matches and both amounts sit within 10% of the approved strengths¹ — closing a common workaround.

The line most likely to matter to a buyer is newer. In its April 1, 2026 update, FDA stated that "at this time, it does not intend to take action against a compounder for compounding a drug product that is essentially a copy of a commercially available drug product regularly or in inordinate amounts if the compounder fills four or fewer prescriptions of that compounded drug product during a calendar month"¹. Read the whole sentence, including "at this time" and the four-prescription ceiling — an enforcement posture with no stated end date, not a volume license. FDA adds that it may still act on any other violation, including a finding that a product is of substandard quality or otherwise unsafe¹.

What section 503B still permits, and what is pending

An outsourcing facility generally cannot compound from a bulk drug substance unless that substance is on the 503B bulks list, or the compounded drug is on FDA's shortage list when it is compounded, distributed, and dispensed¹. Neither applies to semaglutide or tirzepatide. The published bulks list holds five substances, none a GLP-1⁸.

On April 30, 2026, FDA announced it is proposing to exclude semaglutide, tirzepatide, and liraglutide from that list, "finding no clinical need for outsourcing facilities to compound these drugs from bulk substances"². The notice published in the Federal Register on May 1, 2026 under docket FDA-2018-N-3240, and FDA extended the comment period so that comments were due July 30, 2026³⁴. As of August 28, 2026 no final determination had been published. That is a status, not a prediction: the proposal is open, and FDA has said it "will consider submitted comments before making a final determination"².

What is not legal at all

Some products sold as GLP-1 compounds sit outside the framework entirely. FDA states that retatrutide and cagrilintide "cannot be used in compounding under federal law," are not components of any FDA-approved drug, and have not been found safe and effective for any condition⁶. Salt forms are a second category: FDA describes semaglutide sodium and semaglutide acetate as different active ingredients from the one in approved products and says it is "not aware of any lawful basis for their use in compounding"⁶. A third is material labeled "for research purposes" or "not for human consumption" and then sold to consumers with dosing instructions, which FDA has warned companies about⁶. None of the three is compounded medicine under a narrower rule; all fall outside the exemptions that make compounding lawful at all.

What FDA has flagged in the market

FDA also publishes what it has been seeing, with dates attached. As of May 31, 2026 the agency had received 990 adverse event reports associated with compounded semaglutide and more than 730 associated with compounded tirzepatide — a count FDA notes is likely low, since state-licensed pharmacies are not required to report⁶. The problems it names include dosing errors, doses beyond the approved label, products arriving warm or with inadequate refrigeration, and fraudulent labels naming compounding pharmacies that in some cases do not exist⁶. FDA also established a green list import alert, 66-80, for GLP-1 active ingredients with potential quality concerns, which it says "does not create any new limits on the legal compounding of GLP-1 drugs"⁶.

FDA's own consumer red flags work as a checklist: a company claiming its compounded drug is the same as an FDA-approved drug, prices that seem too good to be true, no screening and prescription by a licensed clinician before medicine ships, and no clinician reachable afterward⁶. Compounded drugs are not FDA-approved, and the agency does not review them for safety, effectiveness, or quality before marketing⁷.

Where that leaves a buyer, as of August 2026

Compounded semaglutide from a licensed pharmacy filling a patient-specific prescription is still lawful; the shortage-era model of mass-producing copies is not, and has not been since spring 2025. What changed in 2026 is narrower than headlines suggest: an FDA enforcement statement carrying a four-prescription monthly ceiling, and an open proposal that would close the bulk-substance route for outsourcing facilities once decided. This page covers federal rules only — state boards of pharmacy regulate compounding as well. For how to vet a specific pharmacy, see is compounded semaglutide legit?; for how the two products differ beyond legality, see compounded vs brand-name GLP-1; and for what each pathway costs, see our semaglutide cost breakdown. Regulatory status here reflects FDA and Federal Register records as of August 28, 2026 and can change without notice. This is regulatory context, not legal or medical advice.